S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer
NCT ID: NCT01498289
Last Updated: 2019-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
213 participants
INTERVENTIONAL
2012-02-29
2019-09-19
Brief Summary
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PURPOSE: This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.
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Detailed Description
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* To assess progression-free survival of high-excision repair cross-complementing 1(ERCC1) patients with advanced or metastatic cancer of the esophagus, stomach, or gastroesophageal junction (GEJ) treated with FOLFOX comprising oxaliplatin, leucovorin calcium, and fluorouracil compared to those treated with irinotecan hydrochloride plus docetaxel.
* To assess progression-free survival of low-ERCC1 patients with advanced or metastatic cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to those treated with irinotecan hydrochloride plus docetaxel.
* To assess progression-free survival of low-ERCC1 patients with advanced or metastatic cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to high-ERCC1 patients treated with FOLFOX.
* To assess overall survival of and toxicities in each of the two treatment arms in this group of patients.
* To assess the response probability (confirmed and unconfirmed, complete and partial responses) in the subset of patients with measurable disease in each of the two treatment arms.
* To explore whether there is evidence of interaction between treatment arm and ERCC1 expression in this group of patients. (Exploratory)
* To bank tissue and blood for future translational medicine studies; a) To explore the relationship of ERCC-1 and ERCC-2 single nucleotide polymorphism (SNP) genotypes with clinical outcome in these patients; and b) To explore the association between germline variations in these SNPs and ERCC-1 mRNA expression in these patients. (Exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to ERCC1 expression (high \[≥ 1.7\] vs low \[\< 1.7\]), and disease site (esophageal vs gastric/gastroesophageal junction). Patients are randomized to 1 of 2 treatment arms.
* Arm I (FOLFOX): Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples may be collected for ERCC1 expression analysis and future research studies.
After completion of study treatment, patients are followed up every 3 months for up to 3 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I
FOLFOX regimen: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
FOLFOX regimen
Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium.
fluorouracil
400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.
leucovorin calcium
400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.
oxaliplatin
85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.
Arm II
Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
docetaxel
30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
irinotecan hydrochloride
65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.
Interventions
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FOLFOX regimen
Given IV. Fluorouracil, oxaliplatin, \& leucovorin calcium.
docetaxel
30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
fluorouracil
400 mg/m\^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m\^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.
irinotecan hydrochloride
65 mg/m\^2, IV over 90 minutes on Days 1 \& 8 of every 21 day cycle.
leucovorin calcium
400 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.
oxaliplatin
85 mg/m\^2, IV over 2 hours on Day 1 of every 14 day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have unresectable advanced or metastatic histologically or cytologically confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal junction (GEJ)
* Patients must not have received treatment for metastatic or unresectable disease
* Patients must not have brain metastases
* Patients must have measurable and/or non-measurable disease
* Patients who have had HER-2 expression testing prior to patient consent to this study must be HER-2 negative; if HER-2 expression has not been tested prior to patient consent to this study, a second specimen must be submitted for HER-2 expression; if the specimen is HER-2 positive (or if HER-2 could not be evaluated), the patient will not be randomized
* Patients must have completed any prior neoadjuvant and adjuvant therapy for resectable disease at least 180 days prior to registration
PATIENT CHARACTERISTICS:
* Zubrod performance status of 0-1
* Hemoglobin ≥ 9 g/dL
* Absolute neutrophil count (ANC) ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Total bilirubin ≤ 1.5 mg/dL regardless of whether patients have liver involvement secondary to tumor
* AST and ALT both ≤ 3 times institutional upper limit of normal (IULN) unless the liver is involved with tumor, in which case both AST and ALT must be ≤ 5 times IULN
* Serum creatinine \< 1.5 mg/dL within 28 days prior to registration AND/OR calculated creatinine clearance \> 60 mL/min
* Patients must not have motor or sensory neuropathy \> Grade 1 using CTCAE version 4.0
* Patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* All palliative radiation therapy alone must be completed at least 14 days prior to registration
* Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of therapy for treatment of cancer while on this protocol treatment
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Syma Iqbal, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Mills - Peninsula Hospitals
Burlingame, California, United States
Sutter Davis Hospital
Davis, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
University of Southern California/Norris Cancer Center
Los Angeles, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
Memorial Medical Center
Modesto, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Valley Medical Oncology Consultants
Pleasanton, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter General Hospital
Sacramento, California, United States
University of California at Davis Cancer Center
Sacramento, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Palo Atlo Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Tahoe Forest Cancer Center
Truckee, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Exempla Saint Joseph Hospital
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Colorado Cancer Research Program CCOP
Denver, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Mountain Blue Cancer Care Center
Golden, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Breast Cancer Care Consultants
Greenwood Village, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Littleton Adventist Hospital
Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Parker Adventist Hospital
Parker, Colorado, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Gynecologic Oncology LLC
Newark, Delaware, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Regional Hematology and Oncology PA
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Nanticoke Memorial Hospital
Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Hospital
Orlando, Florida, United States
Memorial Hospital West
Pembroke Pines, Florida, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, United States
John B Amos Cancer Center
Columbus, Georgia, United States
Memorial University Medical Center
Savannah, Georgia, United States
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States
Kuakini Medical Center
Honolulu, Hawaii, United States
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Castle Medical Center
Kailua, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Oncare Hawaii Inc-Pali Momi
‘Aiea, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Joseph Regional Medical Center
Lewiston, Idaho, United States
Idaho Urologic Institute-Meredian
Meridian, Idaho, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
Saint Anthony's Health
Alton, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital Association
Canton, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Hematology and Oncology Associates
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Cancer Care Center of Decatur
Decatur, Illinois, United States
Central Illinois CCOP
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Eureka Hospital
Eureka, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare Galesburg
Galesburg, Illinois, United States
Illinois CancerCare-Galesburg Cottage Plaza Office
Galesburg, Illinois, United States
Illinois CancerCare-Havana
Havana, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States
Presence Saint Mary's Hospital
Kankakee, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Adventist La Grange Memorial Hospital
La Grange, Illinois, United States
North Shore Hematology Oncology
Libertyville, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Mcdonough District Hospital
Macomb, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, United States
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, United States
Spector, David MD (UIA Investigator)
Moline, Illinois, United States
Trinity Medical Center
Moline, Illinois, United States
Holy Family Medical Center
Monmouth, Illinois, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Hematology Oncology Consultants Limited
Naperville, Illinois, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, United States
Bromenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center Foundation
Normal, Illinois, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Pekin Cancer Treatment Center
Pekin, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois Valley Hospital
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Elkhart Clinic
Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States
Franciscan Saint Francis Health-Indianapolis
Indianapolis, Indiana, United States
Community Howard Regional Health
Kokomo, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
Premier Oncology Hematology Associates
Merrillville, Indiana, United States
Memorial Regional Cancer Center Day Road
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Cancer Care Partners LLC
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States
Reid Hospital and Health Care Services
Richmond, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Michiana Hematology Oncology-PC Westville
Westville, Indiana, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States
Hematology Oncology Associates-Quad Cities
Bettendorf, Iowa, United States
McFarland Clinic PC-Boone
Boone, Iowa, United States
Genesis Medical Center - East Campus
Davenport, Iowa, United States
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa, United States
McFarland Clinic PC-Jefferson
Jefferson, Iowa, United States
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, United States
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
Covenant Medical Center
Waterloo, Iowa, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Newman Regional Health
Emporia, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Saint Catherine Hospital
Garden City, Kansas, United States
Saint Rose Ambulatory and Surgery Center
Great Bend, Kansas, United States
Hays Medical Center
Hays, Kansas, United States
Promise Regional Medical Center-Hutchinson
Hutchinson, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Kansas City Cancer Center-West
Kansas City, Kansas, United States
Providence Medical Center
Kansas City, Kansas, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States
Saint Luke's South Hospital
Overland Park, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States
Kansas City CCOP
Prairie Village, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
Kansas City Cancer Center-Shawnee Mission
Shawnee Mission, Kansas, United States
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Wichita CCOP
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, United States
Ochsner Health Center-Summa
Baton Rouge, Louisiana, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Frederick Memorial Hospital
Frederick, Maryland, United States
Bixby Medical Center
Adrian, Michigan, United States
Hickman Cancer Center
Adrian, Michigan, United States
Veteran's Administration Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States
University of Michigan University Hospital
Ann Arbor, Michigan, United States
University of Michigan
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Community Cancer Center of Monroe
Monroe, Michigan, United States
Mercy Memorial Hospital
Monroe, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Lakeland Community Hospital
Niles, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Lakeland Hospital
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Singing River Hospital
Pascagoula, Mississippi, United States
Central Care Cancer Center-Carrie J Babb Cancer Center
Bolivar, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Centerpoint Medical Center LLC
Independence, Missouri, United States
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Truman Medical Center
Kansas City, Missouri, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States
Kansas City Cancer Center - South
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Kansas City Cancer Centers - North
Kansas City, Missouri, United States
Kansas City Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Liberty Hospital
Liberty, Missouri, United States
Phelps County Regional Medical Center
Rolla, Missouri, United States
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Comprehensive Cancer Care PC
St Louis, Missouri, United States
Saint John's Mercy Medical Center
St Louis, Missouri, United States
Montana Cancer Consortium CCOP
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Billings Clinic
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Montana Cancer Specialists
Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Good Samaritan Hospital
Kearney, Nebraska, United States
New Hampshire Oncology-Hematology PA
Concord, New Hampshire, United States
New Hampshire Oncology Hematology Associates
Hooksett, New Hampshire, United States
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States
Inspira Medical Center Vineland
Vineland, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Arnot Ogden Medical Center
Elmira, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
New York University Langone Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Hendersonville Hematology and Oncology at Pardee
Hendersonville, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Park Ridge Hospital Breast Health Center
Hendersonville, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States
Kinston Medical Specialists PA
Kinston, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Southeastern Medical Oncology Center-Wilson
Wilson, North Carolina, United States
Southeast Cancer Control Consortium CCOP
Winston-Salem, North Carolina, United States
Roger Maris Cancer Center
Fargo, North Dakota, United States
Sanford Clinic North-Fargo
Fargo, North Dakota, United States
Sanford Medical Center-Fargo
Fargo, North Dakota, United States
Altru Cancer Center
Grand Forks, North Dakota, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States
Akron General Medical Center
Akron, Ohio, United States
Summa Barberton Hospital
Barberton, Ohio, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, United States
Oncology and Hematology Care Inc-Taft
Cincinnati, Ohio, United States
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, United States
Oncology Hematology Care Inc - Kenwood
Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Health Center
Dayton, Ohio, United States
Dayton CCOP
Dayton, Ohio, United States
Hematology Oncology Center Incorporated
Elyria, Ohio, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, United States
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Saint Rita's Medical Center
Lima, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States
Flower Hospital
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States
Mercy Saint Anne Hospital
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, United States
Greene Memorial Hospital
Xenia, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Oncology Inc
Tulsa, Oklahoma, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States
Warren Cancer Research Foundation
Tulsa, Oklahoma, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Western Oncology Research Consortium
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
AnMed Health Hospital
Anderson, South Carolina, United States
Roper Hospital
Charleston, South Carolina, United States
Charleston Hematology Oncology Associates-Roper
Charleston, South Carolina, United States
Lowcountry Hematology Oncology PA-Charleston
Charleston, South Carolina, United States
Charleston Hematology Oncology Associates PA-St. Francis
Charleston, South Carolina, United States
Lowcountry Hematology Oncology PA-West Ashley
Charleston, South Carolina, United States
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute/Eastside
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Lowcountry Hematology Oncology PA-Mount Pleasant
Mt. Pleasant, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Upstate Carolina CCOP
Spartanburg, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Baylor College of Medicine
Houston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Veterans Administration Medical Center
Houston, Texas, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Cancer Care Center at Island Hospital
Anacortes, Washington, United States
Auburn Regional Medical Center
Auburn, Washington, United States
Overlake Hospital Medical Center
Bellevue, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States
Highline Medical Center-Main Campus
Burien, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Swedish Medical Center-Edmonds
Edmonds, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Saint Francis Hospital
Federal Way, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, United States
Cascade Cancer Center
Kirkland, Washington, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, United States
Saint Clare Hospital
Lakewood, Washington, United States
Saint John Medical Center
Longview, Washington, United States
Skagit Valley Hospital
Mount Vernon, Washington, United States
Providence - Saint Peter Hospital
Olympia, Washington, United States
Capital Medical Center
Olympia, Washington, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States
Good Samaritan Community Hospital
Puyallup, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Minor and James Medical PLLC
Seattle, Washington, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Group Health
Seattle, Washington, United States
Group Health Cooperative-Seattle
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
The Polyclinic
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
United General Hospital
Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, United States
Rockwood Clinic
Spokane, Washington, United States
Allenmore Hospital
Tacoma, Washington, United States
Northwest CCOP
Tacoma, Washington, United States
Northwest Medical Specialties PLLC
Tacoma, Washington, United States
Saint Joseph Medical Center
Tacoma, Washington, United States
Multicare Health System
Tacoma, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Compass Oncology Vancouver
Vancouver, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States
Sacred Heart Hospital
Eau Claire, Wisconsin, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital
Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
Saint Mary's Hospital
Green Bay, Wisconsin, United States
Gundersen Lutheran
La Crosse, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Bay Area Medical Center
Marinette, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States
Saint Mary's Hospital
Rhinelander, Wisconsin, United States
Lakeview Medical Center-Marshfield Clinic
Rice Lake, Wisconsin, United States
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States
Saint Nicholas Hospital
Sheboygan, Wisconsin, United States
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Saint Clare's Hospital
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Riverview Hospital
Wisconsin Rapids, Wisconsin, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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S1201
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-00096
Identifier Type: OTHER
Identifier Source: secondary_id
S1201
Identifier Type: -
Identifier Source: org_study_id
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